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Maquet Medical Systems USA Recall: QUADROX-i Small Adult, Oxygenator used during cardiopul

Maquet Medical Systems USA Recall: QUADROX-i Small Adult, Oxygenator used during cardiopul is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Maquet Medical Systems USA; Product: QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 70106790

Recalling firmMaquet Medical Systems USA
ProductQUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
Reason for recallProduct packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionNationwide domestic distribution
Recall initiated20230518
Recall numberZ-1657-2023
Categorydevice
StateNJ
CountryUnited States

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